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(352) 733-0111

Artisan

  • Status
    Accepting Candidates
  • Age
    22 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    Accepts Healthy Volunteers
I'm interested
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Objective

This study will determine the safety and effectiveness of the Artisan Aphakia Lens when used as a secondary implant to correct aphakia in adults.

Description

Not desired

Details

Full study title Investigational Plan for the Clinical Study of ARTISAN? Aphakia Lens for the Correction of Aphakia in Adults
Protocol number OCR39488
ClinicalTrials.gov ID NCT01547429
Phase N/A

Eligibility

Inclusion Criteria:

  • Patients 22 years of age and over at baseline visit of either sex and of any race where the natural lens has been removed or will be removed and a posterior chamber IOL is not indicated.

  • Patient must agree to comply with the visit schedule and other requirements of the study

Exclusion Criteria:

  • Patients that are not able to meet the extensive postoperative evaluation requirements

  • Mentally retarded patients

  • When the patient has no useful vision or vision potential in the fellow eye

  • History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.), corneal dystrophy, degeneration, opacities or abnormalities that may affect vision.

  • Abnormality of the iris or ocular structure which would preclude fixation, such as aniridia, hemiiridectomy, severe iris atrophy, rubeosis iridis, or other compromising iris pathology

  • Patients with uncontrolled glaucoma

  • High preoperative intraocular pressure, >25 mmHg

  • Chronic or recurrent uveitis or history of the same

  • Preexisting macular pathology that may complicate the ability to assess the benefit or lack of benefit obtained by the lens

  • Patients with a retinal detachment or a family history of retinal detachment

  • Retinal disease that may limit the visual potential of the eye such as retinopathy of prematurity or Stargardt's retinopathy Optic nerve disease that may limit the visual potential of the eye

  • Diabetes mellitus

  • Pregnant, lactating, or plans to become pregnant during the course of this study

Lead researcher

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

    Gibran Khurshid
  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.